Celldex Therapeutics Presents Positive Topline Results from Barzolvolimab Phase 2 Study in Chronic Inducible Urticaria

Clinical Trial Results - Barzolvolimab demonstrated clinically meaningful and statistically significant complete response rates across both dose groups in the Phase 2 clinical trial for chronic inducible urticaria (CIndU) [1] - The study is the first large, randomized, placebo-controlled trial to show success in treating CIndU, specifically cold urticaria (ColdU) and symptomatic dermographism (SD) [1] - Barzolvolimab achieved the primary efficacy endpoint, with 46.9% (150 mg q4w) and 53.1% (300 mg q8w) of ColdU patients showing a negative provocation test at Week 12, compared to 12.5% for placebo [3] - For SD patients, 57.6% (150 mg q4w) and 42.4% (300 mg q8w) achieved a negative provocation test at Week 12, compared to 3.2% for placebo [3] Safety and Tolerability - Barzolvolimab exhibited a favorable safety profile consistent with prior studies, with most adverse events being mild to moderate in severity [3] - The most common treatment-emergent adverse events were hair color changes (13%) and neutropenia (11%) [3] - The rate of infections was similar between barzolvolimab-treated patients and placebo, with no association between neutropenia and infections [3] Study Design and Methodology - The Phase 2 study was a randomized, double-blind, placebo-controlled trial involving 196 patients with CIndU who remained symptomatic despite antihistamine therapy [4] - Patients were divided into two cohorts: 97 with ColdU and 99 with SD, and were randomized to receive barzolvolimab at 150 mg every 4 weeks, 300 mg every 8 weeks, or placebo [4] - The primary endpoint was the percentage of patients with a negative provocation test at Week 12, assessed using TempTest® for ColdU and FricTest® for SD [4][5] Future Development - The company plans to advance barzolvolimab into Phase 3 registration development for CIndU [1] - Full 12-week data from the study will be presented at a medical meeting in the fourth quarter of 2024 [2] About Chronic Inducible Urticaria (CIndU) - CIndU is characterized by hives or wheals triggered by specific stimuli, such as cold temperatures in ColdU or skin scratching/rubbing in SD [7] - Approximately 0.5% of the population suffers from chronic inducible urticarias, with mast cell activation being a key driver of symptoms [7] - There are currently no approved therapies for CIndU other than antihistamines, and patients often manage symptoms by avoiding triggers [7] About Barzolvolimab - Barzolvolimab is a humanized monoclonal antibody that binds and inhibits the receptor tyrosine kinase KIT, which is critical for mast cell function and survival [8] - It is being studied in multiple indications, including chronic spontaneous urticaria (CSU), prurigo nodularis (PN), and eosinophilic esophagitis (EOE), with plans for additional indications like atopic dermatitis (AD) [8] Company Overview - Celldex Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapeutics for severe inflammatory, allergic, and autoimmune diseases [9] - The company’s pipeline includes antibody-based therapeutics targeting mast cell biology and other critical pathways [9]